Trial Outcomes & Findings for Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids (NCT NCT02670382)
NCT ID: NCT02670382
Last Updated: 2021-04-14
Results Overview
plasma levels in pg/mL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
10 weeks
Results posted on
2021-04-14
Participant Flow
405 subjects were screened for eligibility at the Metabolic Research Unit of the Human Nutrition Research Center on Aging at Tufts Unoversity
24 subjects met the inclusion criteria and were enrolled into the study. 3 subjects dropped off during the placebo lead-in phase of the study
Participant milestones
| Measure |
Placebo, Then EPA, Then DHA
3000 mg high oleic acid sunflower oil/day during 4-week lead-in phase; then participants received 3000 mg pure EPA for 10 weeks; then washout of 10 weeks; then pure DHA 3000 mg/day Placebo and EPA and DHA capsules provided as 750 mg/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening
|
Placebo, Then DHA, and Then EPA
3000 mg high oleic acid sunflower oil/day during 4-week lead-in phase; then participants received 3000 mg pure DHA for 10 weeks; then washout of 10 weeks; then pure EPA 3000 mg/day Placebo and DHA and EPA capsules provided as 750 mg/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening
|
|---|---|---|
|
Placebo lead-in Phase
STARTED
|
12
|
12
|
|
Placebo lead-in Phase
COMPLETED
|
10
|
11
|
|
Placebo lead-in Phase
NOT COMPLETED
|
2
|
1
|
|
First Active Intervention
STARTED
|
10
|
11
|
|
First Active Intervention
COMPLETED
|
10
|
11
|
|
First Active Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Active Intervention
STARTED
|
10
|
11
|
|
Second Active Intervention
COMPLETED
|
10
|
11
|
|
Second Active Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo, Then EPA, Then DHA
3000 mg high oleic acid sunflower oil/day during 4-week lead-in phase; then participants received 3000 mg pure EPA for 10 weeks; then washout of 10 weeks; then pure DHA 3000 mg/day Placebo and EPA and DHA capsules provided as 750 mg/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening
|
Placebo, Then DHA, and Then EPA
3000 mg high oleic acid sunflower oil/day during 4-week lead-in phase; then participants received 3000 mg pure DHA for 10 weeks; then washout of 10 weeks; then pure EPA 3000 mg/day Placebo and DHA and EPA capsules provided as 750 mg/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening
|
|---|---|---|
|
Placebo lead-in Phase
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids
Baseline characteristics by cohort
| Measure |
All Participants
n=21 Participants
Baseline characteristic, defined as end of lead-in phase
|
|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
Body mass index
|
32.20 kg/m^2
STANDARD_DEVIATION 6.61 • n=5 Participants
|
|
C reactive protein
|
6.0 microg/mL
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Glucose
|
99 mg/dL
STANDARD_DEVIATION 11 • n=5 Participants
|
|
triglycerides
|
145 mg/dL
STANDARD_DEVIATION 51 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksplasma levels in pg/mL
Outcome measures
| Measure |
Placebo
n=21 Participants
3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.
sunflower oil: 4-week lead-in
|
EPA Intervention
n=21 Participants
Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
EPA: 10 week supplementation
|
DHA Intervention
n=21 Participants
Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
DHA: 10 week supplementation
|
|---|---|---|---|
|
Interleukin-6 (IL-6)
|
0.96 pg/mL
Standard Deviation 0.56
|
1.01 pg/mL
Standard Deviation 0.51
|
0.99 pg/mL
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: 10 weeksplasma levels in pg/mL
Outcome measures
| Measure |
Placebo
n=21 Participants
3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.
sunflower oil: 4-week lead-in
|
EPA Intervention
n=21 Participants
Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
EPA: 10 week supplementation
|
DHA Intervention
n=21 Participants
Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
DHA: 10 week supplementation
|
|---|---|---|---|
|
Tumor Necrosis Factor Alpha (TNF-alpha)
|
2.38 pg/mL
Standard Deviation 0.54
|
2.48 pg/mL
Standard Deviation 0.64
|
2.47 pg/mL
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: 10 weeksplasma levels in mg/dL
Outcome measures
| Measure |
Placebo
n=21 Participants
3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.
sunflower oil: 4-week lead-in
|
EPA Intervention
n=21 Participants
Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
EPA: 10 week supplementation
|
DHA Intervention
n=21 Participants
Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
DHA: 10 week supplementation
|
|---|---|---|---|
|
Low Density Lipoprotein Cholesterol (LDL-C)
|
130 mg/dL
Standard Deviation 26
|
136 mg/dL
Standard Deviation 26
|
140 mg/dL
Standard Deviation 32
|
Adverse Events
EPA Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DHA Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EPA Intervention
n=21 participants at risk
Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
EPA: 10 week supplementation
|
DHA Intervention
n=21 participants at risk
Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
DHA: 10 week supplementation
|
Placebo
n=21 participants at risk
3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.
sunflower oil: 4-week lead-in
|
|---|---|---|---|
|
Metabolism and nutrition disorders
gout
|
0.00%
0/21 • adeverse events were collected during the participation of study subjects, equivalent to 34 weeks
|
0.00%
0/21 • adeverse events were collected during the participation of study subjects, equivalent to 34 weeks
|
4.8%
1/21 • Number of events 1 • adeverse events were collected during the participation of study subjects, equivalent to 34 weeks
|
|
Cardiac disorders
hypertension
|
0.00%
0/21 • adeverse events were collected during the participation of study subjects, equivalent to 34 weeks
|
0.00%
0/21 • adeverse events were collected during the participation of study subjects, equivalent to 34 weeks
|
4.8%
1/21 • Number of events 1 • adeverse events were collected during the participation of study subjects, equivalent to 34 weeks
|
Additional Information
Dr. Stefania Lamon-Fava, Scientist I
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Phone: 617-556-3105
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place